Project: Research project

Project Details


DESCRIPTION: Surgical myocardial
revascularization is a safe, effective and well accepted treatment modality
for severe coronary artery disease. Only recently has the medical
community begun to appreciate that major as well as relatively minor
complications of the procedure may have a significant and long lasting
impact on the patients functional status. The principal objective of this
randomized trial is to assess the safety and efficacy of two strategies of
intra-operative hemodynamic management in preventing peri-operative
cardiac, cognitive and non-cognitive neurologic morbidity and mortality and
post-operative deterioration in the functional status of patients
undergoing elective coronary artery revascularization (CABG). The study is a prospective trial of 248 patients who will be evaluated
pre-operatively, monitored intra-operatively and followed post-operatively
according to a standardized surveillance protocol. Patients will be
randomized to two forms of hemodynamic management during cardiopulmonary
bypass: in one group, the intra-operative MAP will be maintained between
80-100 mm Hg; in the second group, the intra-operative MAP will be
maintained between 50-60 mm Hg. Both are standard, safe approaches to
management. There are five principal outcomes: total mortality at 6 months,
cardiopulmonary morbidity (i.e., myocardial infarction, pulmonary edema,
cardiogenic shock/low flow state), cognitive complications (defined by
intra-patient deterioration on psychometric test of memory, psychomotor
function, and linguistic function), neurologic complications (new focal
deficits, such as hemiplegia, dysphasia, cranial nerve lesions) and
functional status (using the MOS index) at 6 months post-operatively.
Impairment or improvement in physical and mental function at 6 months will
also be documented using patient-specific transition indices that document
changes in the patient's ability to engage in their usual activities.
Changes in the MOS, Beck Depression Inventory, and in life stress and
social integration will be assessed at baseline, 6 and 12 months. The long-term objective is to improve the quality of life and functional
status after CABG. This study will define the impact of post-operative
complications on functional status and determine whether different
approaches to intra-operative hemodynamic management can reduce
post-operative morbidity and prevent post-operative dysfunction.
Effective start/end date8/1/9111/30/00


  • National Institutes of Health: $495,087.00


  • Medicine(all)


Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.